Wording for issuing a CoC for a product that was returned and we have reworked/repaired it and we are sending it back.

Renea Koski QAM

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We are a contract manufacturing company that make surgical instruments. We issues CoC's for all our products. My question is should there be any special wording on the CoC we send to our customer with their returned product after we have addressed their NCR issues? For instance, if they did their incoming inspection and felt a scissors didn't cut. . . we test ALL before releasing . . .and they want to send them back. We fix them and then send them back. What should I say on the CoC? Anything special to notate that this product was reworked??


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CoC is an industry practice; it does not came from a particular regulatory requirement.
I think it's best to stay with one CoC template. Your client should have the NCR report with all the traceability information .

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